propafenone hydrochloride tablet film coated
1 INDICATIONS AND USAGE Propafenone hydrochloride tablets are indicated to: • prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. • prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. • treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital. Usage Considerations: • The use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use propafenone hydrochloride tablets to control ventricular rate during AF. • Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended. • The use of propafenone hydrochloride tablets in patients with chronic atrial fibrillation has not been evaluated. • Because of the proarrhythmic effects of propafenone hydrochloride tablets, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks. • The effect of propafenone on mortality has not been determined [see Boxed Warning ] . Propafenone hydrochloride tablets are an antiarrhythmic indicated to: • prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. ( 1 ) • prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients who do not have structural heart disease. ( 1 ) • treat documented life-threatening ventricular arrhythmias. ( 1 ) Usage Considerations: • Use in patients with permanent atrial fibrillation or with atrial flutter or PSVT has not been evaluated. Do not use to control ventricular rate during atrial fibrillation. ( 1 ) • In patients with atrial fibrillation and atrial flutter, use propafenone hydrochloride tablets with drugs that increase the atrioventricular nodal refractory period. ( 1 ) • Because of proarrhythmic effects, use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic. ( 1 ) • The effect of propafenone on mortality has not been determined. ( 1 )
sun pharmaceutical industries, inc.
ROUND WHITE MP 511
MP 511 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
PROPAFENONE HYDROCHLORIDE tablets are supplied as follows:
PROPAFENONE HYDROCHLORIDE tablets 150 mg, white, round, scored, film-coated, debossed MP 511 Bottles of 30 NDC 53489-551-07 Bottles of 100 NDC 53489-551-01 Bottles of 250 NDC 53489-551-03 Bottles of 500 NDC 53489-551-05 Bottles of 1000 NDC 53489-551-10
PROPAFENONE HYDROCHLORIDE tablets 225 mg, white, round, scored, film-coated, debossed MP 512 Bottles of 30 NDC 53489-552-07 Bottles of 100 NDC 53489-552-01 Bottles of 250 NDC 53489-552-03 Bottles of 500 NDC 53489-552-05 Bottles of 1000 NDC 53489-552-10
PROPAFENONE HYDROCHLORIDE tablets 300 mg, white, round, scored, film-coated, debossed MP 513 Bottles of 30 NDC 53489-553-07 Bottles of 100 NDC 53489-553-01 Bottles of 250 NDC 53489-553-03 Bottles of 500 NDC 53489-553-05 Bottles of 1000 NDC 53489-553-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESIStanT CONTAINER.
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